Trial Outcomes & Findings for Ginger Capsules for the Acute Treatment of Migraine Attacks (NCT NCT02568644)
NCT ID: NCT02568644
Last Updated: 2020-04-07
Results Overview
The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
2 hours
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
Extract of Ginger
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Extract of Ginger
n=30 Participants
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).
Extract of ginger: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).
Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 Participants
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 8.8 • n=30 Participants
|
34.3 years
STANDARD_DEVIATION 9.1 • n=30 Participants
|
33.5 years
STANDARD_DEVIATION 8.9 • n=60 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=30 Participants
|
26 Participants
n=30 Participants
|
52 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Marital Status
Single
|
17 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
32 Participants
n=60 Participants
|
|
Marital Status
Widowed/Divorced
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Marital Status
Married
|
12 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Occupation
Work
|
30 Participants
n=30 Participants
|
25 Participants
n=30 Participants
|
55 Participants
n=60 Participants
|
|
Occupation
Do not work
|
0 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Migraine Diagnosis
Migraine with aura
|
15 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
27 Participants
n=60 Participants
|
|
Migraine Diagnosis
Migraine without aura
|
15 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
33 Participants
n=60 Participants
|
|
Length of disease
|
11.0 years
STANDARD_DEVIATION 10.7 • n=30 Participants
|
10.0 years
STANDARD_DEVIATION 9.6 • n=30 Participants
|
10.5 years
STANDARD_DEVIATION 10.1 • n=60 Participants
|
|
Age of onset the disease
|
21.0 years
STANDARD_DEVIATION 9.8 • n=30 Participants
|
23.1 years
STANDARD_DEVIATION 9.4 • n=30 Participants
|
22.7 years
STANDARD_DEVIATION 9.6 • n=60 Participants
|
|
Number of migraine attacks/month
|
2.2 migraine attacks/month
STANDARD_DEVIATION 1.3 • n=30 Participants
|
2.7 migraine attacks/month
STANDARD_DEVIATION 1.2 • n=30 Participants
|
2.4 migraine attacks/month
STANDARD_DEVIATION 1.2 • n=60 Participants
|
|
Migraine Disability Test (MIDAS)
|
17.4 units on a scale
STANDARD_DEVIATION 14.2 • n=30 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 8.3 • n=30 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 11.2 • n=60 Participants
|
|
Headache Impact Test, version 6 (HIT-6)
|
64.6 units on a scale
STANDARD_DEVIATION 5.5 • n=30 Participants
|
66.9 units on a scale
STANDARD_DEVIATION 4.2 • n=30 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 4.8 • n=60 Participants
|
|
BDI
|
11.2 units on a scale
STANDARD_DEVIATION 6.8 • n=30 Participants
|
13.9 units on a scale
STANDARD_DEVIATION 9.3 • n=30 Participants
|
12.5 units on a scale
STANDARD_DEVIATION 8.0 • n=60 Participants
|
|
Pain intensity (Four-point Scale)
|
2.46 units on a scale
STANDARD_DEVIATION 0.09 • n=30 Participants
|
2.56 units on a scale
STANDARD_DEVIATION 0.09 • n=30 Participants
|
2.51 units on a scale
STANDARD_DEVIATION 0.09 • n=60 Participants
|
|
Pain intensity (Faces Pain Scale)
|
2.90 units on a scale
STANDARD_DEVIATION 0.17 • n=30 Participants
|
2.96 units on a scale
STANDARD_DEVIATION 0.17 • n=30 Participants
|
2.93 units on a scale
STANDARD_DEVIATION 0.17 • n=60 Participants
|
|
Pain intensity (Visual Numeric Scale)
|
7.03 units on a scale
STANDARD_DEVIATION 0.26 • n=30 Participants
|
7.63 units on a scale
STANDARD_DEVIATION 0.25 • n=30 Participants
|
7.33 units on a scale
STANDARD_DEVIATION 0.25 • n=60 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome
Outcome measures
| Measure |
Extract of Ginger
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Change in Headache Severity.
|
0.81 units on a scale
Standard Deviation 0.04
|
0.97 units on a scale
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 2 hoursThe severity of headache was assessed with visual numeric scale. Scale ranges: from zero (absence of pain) to 10 (maximum intensity of pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
Extract of Ginger
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Change in Headache Severity.
|
1.03 units on a scale
Standard Deviation 0.29
|
2.30 units on a scale
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: 2 hoursThe severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain). Higher scores mean a worse outcome.
Outcome measures
| Measure |
Extract of Ginger
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Change in Headache Severity.
|
0.43 units on a scale
Standard Deviation 0.13
|
0.90 units on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Brain derived neurotrophic factor - BDNF (pg/mL)
Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
Outcome measures
| Measure |
Extract of Ginger
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 Participants
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Change in Serum Levels of Biomarkers.
|
6077 BDNF (pg/mL)
Interval 5694.0 to 6944.0
|
6503 BDNF (pg/mL)
Interval 5929.0 to 7244.0
|
Adverse Events
Extract of Ginger
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cellulose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extract of Ginger
n=30 participants at risk
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).
Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
Cellulose
n=30 participants at risk
30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Dizziness
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30
|
6.7%
2/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place